State registration of medical device is a state procedure to ensure that only quality and safe medical devices are introduced into the Russian market.
Article 38, paragraph 4, of the Federal Law dated November 21, 2011 № 323-FZ “On Fundamentals of Healthcare of the Russian Federation Citizens” establishes that medical devices registered by an authorized federal executive body in accordance with the procedure, set by the Government of the Russian Federation are allowed for circulation on the territory of the Russian Federation.
The procedure of the state registration is approved by the Resolution of the Government of the Russian Federation dated by August 12, 2014 №1416 “Approval of regulation of the State Registration of Medical Devices”, the Administrative Regulation of the Federal Service on surveillance in healthcare in Terms of Provision of the State Service of Registration of Medical Devices approved by the Order of the Ministry of Health of the Russian Federation dated October 14, 2013 № 737н.
The definition “State registration of medical devices” includes:
- state registration of medical devices;
- making amendments to the registration certificates;
- issue of a duplicate of the registration certificates;
- making amendments to registration documents;
- replacement of the registration certificates;
- cancellation of state registration.

No, it is strictly prohibited and is the subject for administrative and criminal prosecution.

Regulation of medical devices circulation within the Eurasian Economic Union is carried out in accordance with the Treaty on the Eurasian Economic Union of May 29, 2014, with the Agreement on common principles and rules for the circulation of medical devices (medical devices and medical equipment) within the Eurasian Economic Union of December 23, 2014, other international treaties constituting the law of the Union, the decisions of the Commission, as well as the legislation of the member states. This procedure differs from the Russian State registration procedure. The certificate allows import and sales in the chosen countries of EEU. 

The duration of the registration procedure depends on many factors:

• speed and accuracy of the manufacturer's provision of the necessary information
• speed and accuracy of specimen delivery
• the duration of the tests
• lack of changes in the manufacturer's information during the process
• the duration of Roszdravnadzor's review of the dossier
• efficiency of the registration company's work

In the case of coordinated rapid work of all participants in the process, the duration of registration will be 4-8 months

Properly, in accordance with the requirements of Roszdravnadzor prepare documents and test products. Feel free to contact us, we can help!